Okay, yesterday there were several rather breathless reports in the MSM, about the Supreme Court of Massachusetts holding that Merck, as a branded manufacturer of Propecia®/Proscar®, could be required to stand trial for injuries allegedly caused when someone took not the company's drug -- but a COMPETITOR's generic version. That does sound rather. . . unfair, and would set up some unfortunate incentives -- if it were as broad a ruling as some media reports make it out to be.
In fact, the State of California had previously ruled similarly (but not against Merck) -- and that California case is the more important of the two (more, on that case, likely tomorrow afternoon, after the Ramblers best the Vols, tonight!). I say that because in the local Massachusetts courts yesterday, all the Massachusetts Supreme Judicial Court held was that "willful" or "reckless" failures to update an FDA-mandated label could theoretically result in. . . a branded manufacturer having to stand trial, if a patient taking the generic version is injured, and injured by a risk that the branded manufacturer "recklessly" failed to update the FDA label about.
As a practical matter -- proving a reckless act -- by a multi-national pharma concern, as to a drug that still generates hundreds of millions of dollars for the company -- where the FDA requires a review and pre-approval, for all label changes. . . would be a tall order. Companies like Merck are essentially in constant contact, and negotiations with the FDA staffers -- about emerging pharmacovigilance developments. So -- as I say -- as a practical matter, there is only a negligible chance that a plaintiff could prove recklessness, here.
That said, one of the better reports was filed by Reuters, thus:
. . . .The Massachusetts Supreme Judicial Court ruled that brand-name drugmakers can be sued for recklessness if they intentionally fail to update warning labels for their drugs that makers of cheaper, generic versions must adopt as well. . . .
The top court. . . [ruled] Rafferty [could theoretically] sue Merck for recklessness rather than negligence. This requires a higher standard of proof showing a drugmaker intentionally failed to update its warning label despite knowing the risks.
“Where a brand-name drug manufacturer provides an inadequate warning for its own product, it knows or should know that it puts at risk not only the users of its own product, but also the users of the generic product,” Chief Justice Ralph Gants wrote.
Shielding brand-name manufacturers from liability entirely would leave consumers with no chance to sue generic drug companies, whose products command about 90 percent of the market, Gants wrote for the 4-0 court. . . .
That coverage at least gets it right -- but fails to provide the broader context, for how difficult "willfulness" proof would be, in this setting.
So then, to California tomorrow -- as I have a team to cheer on, and some green-hued vanilla milkshake to down, after my workout today. . . . chasing my grown triathlete son, who will lap me several times, over the course of a mile, the pool, in a bit. But I will have small green shamrocks tattoos to my cheeks, for . . .absolute "Black Irish" power! Smile. . . .
नमस्ते
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